Guidance document: 150-13 Revised: November 6, 2018

Virginia Board of Veterinary Medicine

Controlled Substances (Schedule II-VI) in Veterinary Practice

Veterinarians are allowed to prescribe, administer, and dispense controlled substances in keeping with the requirements of the Virginia Drug Control Act, specifically § 54.1-3409 of the Code of Virginia , and the statutes and regulations governing the practice of veterinary medicine. A bona fide veterinarian-client-patient relationship (VCPR) as set forth in § 54.1-3303 of the Code of Virginia, must first exist before drugs may be prescribed by a veterinarian.

Veterinary prescriptions

The Board of Veterinary Medicine often receives questions regarding what is required of a veterinarian in prescribing or dispensing a prescription for controlled substances. In Virginia, the term “controlled substances” is defined as any prescription drug including Schedule VI drugs . The most frequently asked questions are the following: 1. What authority does a veterinarian have to prescribe? 2. Does a veterinarian have a right to refuse to provide a prescription? 3. May a veterinarian charge a fee for writing the prescription? 4. What information is required on a prescription and in what format? 5. Are there any prescription requirements specific to a Schedule II drug? 6. Does a veterinarian have to honor a prescription request by a pharmacy sent via telephone or fax? 7. What is required of a pharmacist in filling a prescription? 8. May one veterinary establishment “fill a prescription” for a patient seen by a veterinarian at another establishment? 9. May a veterinarian purchase controlled substances for the purpose of reselling? 10. May a veterinarian or veterinary establishment donate an expired or unexpired controlled substance (Schedule II – VI)? 11. May an owner return or donate an unused Schedule II – V drug to a veterinarian that was dispensed to an animal or a human? 12. May an owner return or donate an unused Schedule VI drug to a veterinarian that was dispensed to an animal or a human? 13. May a veterinarian provide a general stock of controlled drugs (Schedule II – VI) for administrating or dispensing by a pet store establishment or boarding kennel? 14. May a veterinarian prescribe cannabidiol (CBD) oil? 15. May a veterinarian prescribe opioids? 16. Does a veterinarian have a requirement to report to the Prescription Monitoring Program (PMP) when controlled substances are dispensed from a veterinary establishment?

1. What authority does a veterinarian have to prescribe?

Veterinarians are authorized to prescribe Schedule II through VI drugs by federal and state law. While not a comprehensive listing of all relevant federal and state law, the Virginia Drug Control Act provides:

§ 54.1-3409. Professional use by veterinarians.

A veterinarian may not prescribe controlled substances for human use and shall only prescribe, dispense or administer a controlled substance in good faith for use by animals within the course of

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his professional practice. He may prescribe, on a written prescription or on oral prescription as authorized by § 54.1-3410. . . Such a prescription shall be dated and signed by the person prescribing on the day when issued, and shall bear the full name and address of the owner of the animal, and the species of the animal for which the drug is prescribed and the full name, address and registry number, under the federal laws of the person prescribing, if he is required by those laws to be so registered.

However, the following portions of §§54.1-3408 and 54.1-3303 also apply, and they detail what is required to render a valid prescription.

§ 54.1-3408. Professional use by practitioners.

A. A practitioner of … veterinary medicine… shall only prescribe, dispense, or administer controlled substances in good faith for medicinal or therapeutic purposes within the course of his professional practice.

B. The prescribing practitioner's order may be on a written prescription or pursuant to an oral prescription as authorized by this chapter…

§ 54.1-3303. Prescriptions to be issued and drugs to be dispensed for medical or therapeutic purposes only.

A. A prescription for a controlled substance may be issued only by a practitioner of . . . veterinary medicine who is authorized to prescribe controlled substances… B. A prescription shall be issued only to persons or animals with whom the practitioner has a bona fide practitioner-patient relationship or veterinarian-client-patient relationship.

For purposes of this section, a bona fide veterinarian-client-patient relationship is one in which a veterinarian, another veterinarian within the group in which he practices, or a veterinarian with whom he is consulting has assumed the responsibility for making medical judgments regarding the health of and providing medical treatment to an animal as defined in § 3.2-6500 , other than an equine as defined in § 3.2- 6200 , a group of agricultural animals as defined in § 3.2-6500 , or bees as defined in § 3.2-4400 , and a client who is the owner or other caretaker of the animal, group of agricultural animals, or bees has consented to such treatment and agreed to follow the instructions of the veterinarian. Evidence that a veterinarian has assumed responsibility for making medical judgments regarding the health of and providing medical treatment to an animal, group of agricultural animals, or bees shall include evidence that the veterinarian (A) has sufficient knowledge of the animal, group of agricultural animals, or bees to provide a general or preliminary diagnosis of the medical condition of the animal, group of agricultural animals, or bees; (B) has made an examination of the animal, group of agricultural animals, or bees, either physically or by the use of instrumentation and diagnostic equipment through which images and medical records may be transmitted electronically or has become familiar with the care and keeping of that species of animal or bee on the premises of the client, including other premises within the same operation or production system of the client, through medically appropriate and timely visits to the premises at which the animal, group of agricultural animals, or bees are kept; and (C) is available to provide follow-up care. It should be noted that the pharmacist who fills the prescription must determine if the prescription is valid, and part of this determination involves establishing that a bona fide practitioner-patient-client- pharmacist relationship exists as provided in § 54.1-3303.

2. Does the veterinarian have the right to refuse to provide a prescription?

The Regulations Governing the Practice of Veterinary Medicine, 18VAC150-20-140(6) and (12), provide that it is unprofessional conduct to violate any state law, federal law, or board regulation pertaining to the practice of

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veterinary medicine and to refuse to release a copy of a valid prescription upon request from a client. The Board has held consistently that it is unprofessional conduct for a veterinarian to refuse to provide a prescription to a client if he would have dispensed the medication for the patient from his own animal facility. This does not mean that the veterinarian is compelled to release a prescription when requested if there are medical reasons for not releasing it and he would not dispense the medication from his own practice.

Prior to issuance of a refill authorization of a prescription, the decision to require an examination of the animal is at the discretion of the professional judgment of the treating veterinarian.

3. May a veterinarian charge a fee for writing the prescription?

There is nothing in statute or regulation to prohibit a practitioner from charging a reasonable fee for writing the prescription if he so chooses.

4. What information is required on a prescription and in what format?

§ 54.1-3408.01. Requirements for prescriptions.

A. The written prescription referred to in § 54.1-3408 shall be written with ink or individually typed or printed. The prescription shall contain the name, address, and telephone number of the prescriber. A prescription for a controlled substance other than one controlled in Schedule VI shall also contain the federal controlled substances registration number assigned to the prescriber. The prescriber's information shall be either preprinted upon the prescription blank, electronically printed, typewritten, rubber stamped, or printed by hand.

The written prescription shall contain the first and last name of the patient for whom the drug is prescribed. The address of the patient shall either be placed upon the written prescription by the prescriber or his agent, or by the dispenser of the prescription. If not otherwise prohibited by law, the dispenser may record the address of the patient in an electronic prescription dispensing record for that patient in lieu of recording it on the prescription. Each written prescription shall be dated as of, and signed by the prescriber on, the day when issued. The prescription may be prepared by an agent for the prescriber's signature.

This section shall not prohibit a prescriber from using preprinted prescriptions for drugs classified in Schedule VI if all requirements concerning dates, signatures, and other information specified above are otherwise fulfilled.

No written prescription order form shall include more than one prescription. . .

C. The oral prescription referred to in §54.1-3408 shall be transmitted to the pharmacy of the patient's choice by the prescriber or his authorized agent. For the purposes of this section, an authorized agent of the prescriber shall be an employee of the prescriber who is under his immediate and personal supervision, or if not an employee, an individual who holds a valid license allowing the administration or dispensing of drugs and who is specifically directed by the prescriber.

§ 54.1-3409. Professional use by veterinarians.

He may prescribe, on a written prescription or on oral prescription as authorized by § 54.1-3410...Such a prescription shall be dated and signed by the person prescribing on the day when issued, and shall bear the full name and address of the owner of the animal, and the species of the animal for which the drug is

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prescribed and the full name, address and registry number, under the federal laws of the person prescribing, if he is required by those laws to be so registered.

5. Are there any prescription requirements specific to a Schedule II drug?

In addition to the prescription requirements found in the response to Question 4 above, the following information is provided for writing prescriptions for Schedule II drugs:

§ 54.1-3411. When prescriptions may be refilled.

Prescriptions may be refilled as follows:

1. A prescription for a drug in Schedule II may not be refilled.

In addition, answers to the following questions related to multiple prescriptions may be found on the DEA’s website located at https://www.deadiversion.usdoj.gov/faq/mult_rx_faq.htm :

DEA Questions & Answers - Issuance of Multiple Prescriptions for Schedule II Controlled Substances What does this rule allow a practitioner to do? What are the requirements for the issuance of multiple prescriptions for schedule II controlled substances? Does this rule require or mandate a practitioner to issue multiple prescriptions for schedule II controlled substances? What is the effective date of the rule change? Is there a limit on the number of schedule II dosage units a practitioner can prescribe to a patient? Is there a limit on the number of separate prescriptions per schedule II substance that may be issued during the 90-day time period? How is the issuance of multiple schedule II prescriptions different than issuing a refill of a schedule II prescription? Is post-dating of multiple prescriptions allowed? What is expected of the pharmacist?

6. Does a veterinarian have to honor a prescription request by a pharmacy sent via telephone or fax?

A veterinarian may honor such a request if a valid veterinarian-client-patient relationship exists as described previously and the veterinarian is sure that the client has requested it. However, the veterinarian is not compelled to do so. Section §54.1-3408.02 allows the transmission of faxed prescriptions.

§ 54.1-3408.02. Transmission of prescriptions.

Consistent with federal law and in accordance with regulations promulgated by the Board [of Pharmacy], prescriptions may be transmitted to a pharmacy by electronic transmission or by facsimile machine and shall be treated as valid original prescriptions.

7. What is required of a pharmacist in filling a prescription?

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§ 54.1-3410. When pharmacist may sell and dispense drugs.

A. A pharmacist, acting in good faith, may sell and dispense drugs and devices to any person pursuant to a prescription of a prescriber as follows:

1. A drug listed in Schedule II shall be dispensed only upon receipt of a written prescription that is properly executed, dated and signed by the person prescribing on the day when issued and bearing the full name and address of the patient for whom, or of the owner of the animal for which, the drug is dispensed, and the full name, address, and registry number under the federal laws of the person prescribing, if he is required by those laws to be so registered. If the prescription is for an animal, it shall state the species of animal for which the drug is prescribed;

2. In emergency situations, Schedule II drugs may be dispensed pursuant to an oral prescription in accordance with the Board's[of Pharmacy]regulations;

3. Whenever a pharmacist dispenses any drug listed within Schedule II on a prescription issued by a prescriber, he shall affix to the container in which such drug is dispensed, a label showing the prescription serial number or name of the drug; the date of initial filling; his name and address, or the name and address of the pharmacy; the name of the patient or, if the patient is an animal, the name of the owner of the animal and the species of the animal; the name of the prescriber by whom the prescription was written;…and such directions as may be stated on the prescription.

B. A drug controlled by Schedules III through VI or a device controlled by Schedule VI shall be dispensed upon receipt of a written or oral prescription as follows:

1. If the prescription is written, it shall be properly executed, dated and signed by the person prescribing on the day when issued and bear the full name and address of the patient for whom, or of the owner of the animal for which, the drug is dispensed, and the full name and address of the person prescribing. If the prescription is for an animal, it shall state the species of animal for which the drug is prescribed.

2. If the prescription is oral, the prescriber shall furnish the pharmacist with the same information as is required by law in the case of a written prescription for drugs and devices, except for the signature of the prescriber. A pharmacist who dispenses a Schedule III through VI drug or device shall label the drug or device as required in subdivision A 3 of this section.

C. A drug controlled by Schedule VI may be refilled without authorization from the prescriber if, after reasonable effort has been made to contact him, the pharmacist ascertains that he is not available and the patient's health would be in imminent danger without the benefits of the drug. The refill shall be made in compliance with the provisions of § 54.1-3411. If the written or oral prescription is for a Schedule VI drug or device and does not contain the address or registry number of the prescriber, or the address of the patient, the pharmacist need not reduce such information to writing if such information is readily retrievable within the pharmacy.

D. Pursuant to authorization of the prescriber, an agent of the prescriber on his behalf may orally transmit a prescription for a drug classified in Schedules III through VI if, in such cases, the written record of the prescription required by this subsection specifies the full name of the agent of the prescriber transmitting the prescription.

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8. May one veterinary establishment “fill a prescription” for a patient seen by a veterinarian at another establishment?

No. There is no provision in Virginia law that allows for veterinary establishments or any other establishment not duly licensed by the Board of Pharmacy to dispense controlled substances to fill a prescription.

9. May a veterinarian purchase controlled substances (including Schedule VI drugs and devices) for the purpose of reselling?

No. A veterinarian does not have statutory authority to purchase controlled drugs for the purpose of wholesaling to a pharmacy, another practitioner, a veterinary establishment or commercial entity.

10. May a veterinarian or veterinary establishment donate an expired or unexpired controlled substance (Schedule II – VI)?

The meaning of “donation” in this context refers to the transferring of controlled substances without a prescription. A veterinarian may opt to not charge for a properly dispensed controlled substance. Expired Schedule II – VI Controlled Substances. There is no authority to donate expired substances because they may be considered adulterated and must be destroyed in accordance with federal and state laws and regulations.

Unexpired Schedule II-VI Controlled Substances The Drug Enforcement Agency (DEA) only permits the transfer of a Schedule II-V drug from one DEA registrant to another DEA registrant regardless of payment method.

11. May an owner return or donate an unused Schedule II – V drug to a veterinarian that was dispensed to a pet or human?

The Drug Enforcement Agency (DEA) only permits the transfer of Schedule II-V drug from one DEA registrant to another DEA registrant. Because the patient/client is not a DEA registrant, he may not transfer a Schedule II-V drug to anyone except during a drug take-back event wherein law enforcement receives the drug from the patient/client for destruction purposes only. Violations of this requirement can result in DEA imposing on the veterinarian a $10,000 fine per incident.

§ 54.1-3411.1. Prohibition on returns, exchanges, or re-dispensing of drugs; exceptions.

A. Drugs dispensed to persons pursuant to a prescription shall not be accepted for return or exchange for the purpose of re-dispensing by any pharmacist or pharmacy after such drugs have been removed from the pharmacy premises from which they were dispensed except:

1. In a hospital with an on-site hospital pharmacy wherein drugs may be returned to the pharmacy in accordance with practice standards;

2. In such cases where official compendium storage requirements are assured and the drugs are in manufacturers' original sealed containers or in sealed individual dose or unit dose packaging that meets official compendium class A or B container requirements, or better, and such return or exchange is consistent with federal law; or

3. When a dispensed drug has not been out of the possession of a delivery agent of the pharmacy.

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B. The Board of Pharmacy shall promulgate regulations to establish a Prescription Drug Donation Program for accepting unused previously dispensed prescription drugs that meet the criteria set forth in subdivision A 2, for the purpose of re-dispensing such drugs to indigent patients, either through hospitals, or through clinics organized in whole or in part for the delivery of health care services to the indigent. Such program shall not authorize the donation of Schedule II-V controlled substances if so prohibited by federal law. No drugs shall be re-dispensed unless the integrity of the drug can be assured.

C. Unused prescription drugs dispensed for use by persons eligible for coverage under Title XIX or Title XXI of the Social Security Act, as amended, may be donated pursuant to this section unless such donation is prohibited.

D. A pharmaceutical manufacturer shall not be liable for any claim or injury arising from the storage, donation, acceptance, transfer, or dispensing of any drug provided to a patient, or any other activity undertaken in accordance with a drug distribution program established pursuant to this section.

E. Nothing in this section shall be construed to create any new or additional liability, or to abrogate any liability that may exist, applicable to a pharmaceutical manufacturer for its products separately from the storage, donation, acceptance, transfer, or dispensing of any drug provided to a patient in accordance with a drug distribution program established pursuant to this section.

12. May an owner return or donate an unused Schedule VI drug to a veterinarian that was dispensed to a pet or a human?

While state law does not prohibit a veterinarian from receiving back an already dispensed Scheduled VI drug for destruction purposes, there is no provision in law for a veterinarian to re-dispense this returned drug.

13. May a veterinarian provide a general stock of controlled drugs (Schedule II – VI) for administrating or dispensing by a pet store establishment or boarding kennel?

There is no allowance in law for a veterinarian to provide a pet store establishment or boarding kennel with a general stock of controlled substances to be given to animals, either by donation or for a fee. In Virginia, the term “controlled substances” is defined as any prescription drug including Schedule VI drugs . The meaning of “donation” in this context refers to the transferring of controlled substances without a prescription. However, a veterinarian may opt to not charge for a properly dispensed controlled substance. A veterinarian is allowed to prescribe, administer, and dispense controlled substances in keeping with the requirements of the Virginia Drug Control Act, specifically § 54.1-3409 of the Code of Virginia , and the statutes and regulations governing the practice of veterinary medicine. A veterinarian may prescribe, label and dispense a drug for the treatment of a specific animal after establishing a bona fide veterinarian-client-patient relationship.

14. May a veterinarian issue a written certification for cannabidiol oil or THC-A oil?

Pursuant to the Code of Virginia, a veterinarian is not included in the definition of a “practitioner” who is authorized to issue written certification for possession and use of cannabidiol oil or THC-A oil.

In 2018, legislation was passed amending §§ 54.1-3408.3 and 18.2-250.1, relating to cannabidiol oil or THC-A oil and possession of marijuana.

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§ 54.1-3408.3. Certification for use of cannabidiol oil or THC-A oil for treatment.

A. As used in this section:

"Cannabidiol oil" means a processed Cannabis plant extract that contains at least 15 percent cannabidiol but no more than five percent tetrahydrocannabinol, or a dilution of the resin of the Cannabis plant that contains at least five milligrams of cannabidiol per milliliter but not more than five percent tetrahydrocannabinol.

"Practitioner" means a practitioner of medicine or osteopathy licensed by the Board of Medicine.

"THC-A oil" means a processed Cannabis plant extract that contains at least 15 percent tetrahydrocannabinol acid but not more than five percent tetrahydrocannabinol, or a dilution of the resin of the Cannabis plant that contains at least five milligrams of tetrahydrocannabinol acid per milliliter but not more than five percent tetrahydrocannabinol.

B. A practitioner in the course of his professional practice may issue a written certification for the use of cannabidiol oil or THC-A oil for treatment or to alleviate the symptoms of any diagnosed condition or disease determined by the practitioner to benefit from such use.

D. No practitioner shall be prosecuted under § 18.2-248 or 18.2-248.1 for dispensing or distributing cannabidiol oil or THC-A oil for the treatment or to alleviate the symptoms of a patient's diagnosed condition or disease pursuant to a written certification issued pursuant to subsection B. Nothing in this section shall preclude the Board of Medicine from sanctioning a practitioner for failing to properly evaluate or treat a patient's medical condition or otherwise violating the applicable standard of care for evaluating or treating medical conditions.

§ 18.2-250.1. Possession of marijuana unlawful.

A. It is unlawful for any person knowingly or intentionally to possess marijuana unless the substance was obtained directly from, or pursuant to, a valid prescription or order of a practitioner while acting in the course of his professional practice, or except as otherwise authorized by the Drug Control Act (§ 54.1-3400 et seq.).

Upon the prosecution of a person for violation of this section, ownership or occupancy of the premises or vehicle upon or in which marijuana was found shall not create a presumption that such person either knowingly or intentionally possessed such marijuana.

Any person who violates this section is guilty of a misdemeanor and shall be confined in jail not more than 30 days and fined not more than $500, either or both; any person, upon a second or subsequent conviction of a violation of this section, is guilty of a Class 1 misdemeanor.

B. The provisions of this section shall not apply to members of state, federal, county, city, or town law-enforcement agencies, jail officers, or correctional officers, as defined in § 53.1-1,

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certified as handlers of dogs trained in the detection of controlled substances when possession of marijuana is necessary for the performance of their duties.

C. In any prosecution under this section involving marijuana in the form of cannabidiol oil or THC-A oil as those terms are defined in § 54.1-3408.3, it shall be an affirmative defense that the individual possessed such oil pursuant to a valid written certification issued by a practitioner in the course of his professional practice pursuant to § 54.1-3408.3 for treatment or to alleviate the symptoms of (i) the individual's diagnosed condition or disease or (ii) if such individual is the parent or legal guardian of a minor or of an incapacitated adult as defined in § 18.2-369, such minor's or incapacitated adult's diagnosed condition or disease. If the individual files the valid written certification with the court at least 10 days prior to trial and causes a copy of such written certification to be delivered to the attorney for the Commonwealth, such written certification shall be prima facie evidence that such oil was possessed pursuant to a valid written certification.

15. May a veterinarian prescribe opioids?

Pursuant to 18VAC150-20-180 of the Regulations Governing the Practice of Veterinary Medicine , a veterinarian may prescribe Schedule II-V drugs that contains an opioid, to include tramadol and buprenorphine.

18VAC150-20-174. Prescribing of controlled substances for pain or chronic conditions. A. Evaluation of the patient and need for prescribing a controlled substance for pain. 1. For the purposes of this section, a controlled substance shall be a Schedules II through V drug, as set forth in the Drug Control Act (§ 54.1-3400 et seq. of the Code of Virginia), which contains an opioid, to include tramadol and buprenorphine. 2. Nonpharmacologic and non-opioid treatment for pain shall be given consideration prior to treatment with opioids. Prior to initiating treatment with a controlled substance, as defined, the prescriber shall perform a history and physical examination appropriate to the complaint and conduct an assessment of the patient's history as part of the initial evaluation. 3. If a controlled substance is necessary for treatment of acute pain, the veterinarian shall prescribe it in the lowest effective dose appropriate to the size and species of the animal for the least amount of time. The initial dose shall not exceed a 14-day supply. B. If the prescribing is within the accepted standard of care, a veterinarian may prescribe a controlled substance containing an opioid for management of chronic pain, terminal illnesses, or certain chronic conditions, such as chronic heart failure, chronic bronchitis, osteoarthritis, collapsing trachea, or related conditions. 1. For prescribing a controlled substance for management of pain after the initial 14-day prescription referenced in subsection A of this section, the patient shall be seen and evaluated for the continued need for an opioid. For the prescribing of a controlled substance for terminal illnesses or certain chronic conditions, it is not required to see and reevaluate the patient for prescribing beyond 14 days. 2. For any prescribing of a controlled substance beyond 14 days, the veterinarian shall develop a treatment plan for the patient, which shall include measures to be used to determine progress in treatment, further diagnostic evaluations or modalities that might be necessary, and the extent to which the pain or condition is associated with physical impairment. 3. For continued prescribing of a controlled substance, the patient shall be seen and reevaluated at least every six months, and the justification for such prescribing documented in the patient record.

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C. Prior to prescribing or dispensing a controlled substance, the veterinarian shall document a discussion with the owner about the known risks and benefits of opioid therapy, the responsibility for the security of the drug and proper disposal of any unused drug. D. Continuation of treatment with controlled substances shall be supported by documentation of continued benefit from the prescribing. If the patient's progress is unsatisfactory, the veterinarian shall assess the appropriateness of continued use of the current treatment plan and consider the use of other therapeutic modalities. E. The medical record for prescribing controlled substances shall include signs or presentation of the pain or condition, a presumptive diagnosis for the origin of the pain or condition, an examination appropriate to the complaint, a treatment plan, and the medication prescribed to include the date, type, dosage, and quantity prescribed.

16. Does a veterinarian have a requirement to report to the Prescription Monitoring Program (PMP) when controlled substance are dispensed from a veterinary establishment?

The 2018 General Assembly passed SB226 requiring all veterinarians to report the dispensing of covered substances for a course of treatment to last more than seven days. Please review the FAQs on Mandatory PMP Reporting Requirements for Veterinarians for more information on this requirement.

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